Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The primary aim of this study is to verify if a significant reduction in total procedural X-ray dose during electrophysiological interventions can be achieved by using advanced image processing (Allura Clarity).
X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose. In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a new algorithm that is capable to process images with similar image quality but acquired at lower dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
136
Acquisition of x-ray images with reduced X-ray dose and advanced image processing
Acquisition of x-ray images with regular X-ray dose and regular image processing
Catharina Ziekenhuis
Eindhoven, Netherlands
Cumulative Dose Area Product (DAP) Value
Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.
Time frame: Day 0
Cumulative Air Kerma (AK) Value
Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.
Time frame: Day 0
Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)
Staff dose measured by Electronic Personal Dosimeter (EPD) worn by the operator over the lead apron (EPD operator) and the other mounted at a fixed location in the EP laboratory (EPD fixed)
Time frame: Day 0
Physician Professional Judgment on Procedural Success
Measurement of professional judgment (yes/no) of the treating physician.
Time frame: Day 0
Procedure Duration
Time frame: Day 0
Fluoroscopy Time
Time frame: Day 0
Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure
If fluoroscopy time (see results in other secondary outcomes), number of exposure frames (see below) and procedure duration (see results in other secondary outcomes) are equivalent between the two groups, this will indicate that image quality (IQ) is equally adequate in both groups.
Time frame: Day 0
Usage of Physician Controlled Dose Settings
In both groups, default fluoroscopy dose settings were 'low', but could be changed by the operator to a medium or high setting for better imaging. The necessity to increase fluoroscopy dose for better imaging to medium or high was registered as a percentage of total number of fluoroscopy frames.
Time frame: Day 0
Serious Adverse Events
Time frame: Day 0 if any
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